COAGADEX- coagulation factor x human kit

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

Coagulation Factor X Human (UNII: 0P94UQE6SY) (Coagulation Factor X Human - UNII:0P94UQE6SY)

זמין מ:

Bio Products Laboratory Limited

INN (שם בינלאומי):

Coagulation Factor X Human

הרכב:

Coagulation Factor X Human 100 [iU] in 1 mL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

COAGADEX, Coagulation Factor X (Human), is a plasma-derived human blood coagulation Factor indicated in adults and children with hereditary Factor X deficiency for: - Routine prophylaxis to reduce the frequency of bleeding episodes - On-demand treatment and control of bleeding episodes - Perioperative management of bleeding in patients with mild, moderate, and severe hereditary Factor X deficiency COAGADEX is contraindicated in patients who have had life-threatening hypersensitivity reactions to COAGADEX [see Description (11) ]. Risk Summary There is limited data with COAGADEX in pregnant women to inform on drug-associated risk. Animal reproduction studies have not been conducted using COAGADEX. It is not known whether COAGADEX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Risk Summary Ther

leaflet_short:

How Supplied COAGADEX is supplied in single-dose glass vials containing a nominal (approximate) 250 IU or 500 IU (approximately 100 IU/mL after reconstitution) of Factor X activity, packaged with 2.5 mL or 5 mL of Sterile Water for Injection, respectively, and a Mix2Vial transfer device. The vials are closed with a synthetic rubber stopper. The stopper is not made with natural rubber latex. The stopper is secured with an aluminum overseal with a flip-off polypropylene cap. Storage and Handling

מצב אישור:

Biologic Licensing Application

מאפייני מוצר

COAGADEX- COAGULATION FACTOR X HUMAN
BIO PRODUCTS LABORATORY LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COAGADEX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR COAGADEX .
COAGADEX (COAGULATION FACTOR X (HUMAN))
LYOPHILIZED POWDER FOR SOLUTION FOR INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: [2015]
RECENT MAJOR CHANGES
INDICATIONS AND USAGE (1)
4/2023
DOSAGE AND ADMINISTRATION (2, 2.1, 2.3)
4/2023
INDICATIONS AND USAGE
COAGADEX, Coagulation Factor X (Human), is a plasma-derived human
blood coagulation factor indicated
in adults and children with hereditary Factor X deficiency for:
Routine prophylaxis to reduce the frequency of bleeding episodes (1)
On-demand treatment and control of bleeding episodes (1)
Perioperative management of bleeding in patients with mild, moderate
and severe hereditary Factor X
deficiency (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY AFTER RECONSTITUTION.
Each vial of COAGADEX contains the labeled amount of Factor X in
international units (IU) (2)
The dosage and duration of treatment depend on the severity of the
Factor X deficiency, the location
and extent of the bleeding and the patient's clinical condition (2.1)
For prophylaxis of bleeding episodes (2.1):
AGE
INITIAL DOSE
FURTHER MANAGEMENT
CHILDREN: Less than 12 years of age 40 IU/kg twice weeklyMonitor
trough blood levels of Factor X
targeting ≥5 IU/dL and adjust dosage to clinical
response and trough levels. Do not exceed a
peak level of 120 IU/dL.
ADULTS AND ADOLESCENTS: 12
years of age or older
25 IU/kg twice weekly
For treatment of bleeding episodes (2.1):
AGE
INITIAL DOSE
FURTHER MANAGEMENT
CHILDREN: Less than 12 years of age
30 IU/kg
Infuse at first sign of bleeding. Repeat at
intervals of 24 hours until the bleed stops.
ADULTS AND ADOLESCENTS: 12
years of age or older
25 IU/kg
For perioperative management (2.1):
AGE
INITIAL DOSE
FURTHER MANAGEMENT
CHILDREN: Less than 12 years of age
Use a factor of 0.6
to calculate the
requi